Application 204835
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFIXIME | CEFIXIME | FOR SUSPENSION;ORAL | 100MG/5ML | No | No |
| 002 | CEFIXIME | CEFIXIME | FOR SUSPENSION;ORAL | 200MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-751 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
| 65862-751 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
| 65862-751 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
| 65862-751 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
| 65862-752 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
| 65862-752 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
| 65862-752 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
| 65862-752 | Cefixime | cefixime | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32599 | ORIG | 2015-04-24 |